Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals'Kinrix · 1 trial · 3 indications
Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as: * initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of \< 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL) * initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination
anti-PT, anti-FHA and anti-PRN booster response : * initially sero- (pre-booster antibody concentration below cut-off \< 5.0 EL.U/mL) with increase of at least four times cut-off one month after vaccination (concentration post-booster ≥20.0 EL.U/mL) * initially sero+ with pre-booster antibody concentration ≥5.0 EL.U/mL and \< 20.0 EL.U/mL with increase of at least four times pre-booster concentration one month post-booster * initially sero+ with pre-booster antibody concentration ≥20.0 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month post-booster
Titers are expressed as GMTs.
| Arm | Type | Description |
|---|---|---|
| Kinrix + M-M-R II + Varivax | EXPERIMENTAL | Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively. |
| Kinrix + M-M-R II -> Varivax | ACTIVE_COMPARATOR | Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals'Kinrix® | BIOLOGICAL | One dose as intramuscular injection at visit 1 |
| Merck and Company's MMRII | BIOLOGICAL | One dose as subcutaneous injection at visit 1 |
| Merck and Company's Varivax | BIOLOGICAL | One dose as subcutaneous injection at visit 1 or at visit 2 |
Inclusion Criteria: * Subjects for whom the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol. * A male or female child between 4 and 6 years of age, inclusive. * Written informed consent obtained from the parent or guardian of the subject...
Kinrix is a vaccine developed by GSK plc for the prevention of tetanus, as well as acellular pertussis and diphtheria. It is intended for use in healthy children aged 4 to 6 years, as part of a vaccination schedule to boost immunity against these infectious diseases.
Kinrix is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is responsible for the research, clinical development, and manufacturing of this vaccine candidate.
Kinrix is in Phase 3 clinical development. It has completed one Phase 3 trial, which was an active-controlled study. The vaccine is still investigational and has not been approved for use, as it remains in the clinical development stage.
Kinrix has been studied in one completed Phase 3 clinical trial, identified as NCT00871117. This trial evaluated the immunogenicity and safety of Kinrix when given with the Measles Mumps Rubella (MMR) vaccine, with and without the varicella vaccine, in healthy children aged 4 to 6 years in the United States.
No, Kinrix is not the same as the MMR vaccine. Kinrix is a vaccine against tetanus, acellular pertussis, and diphtheria, while the MMR vaccine protects against measles, mumps, and rubella. In clinical trials, Kinrix has been studied in combination with the MMR vaccine to assess its safety and immunogenicity.